Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Neurogenic Bladder Clinical Trial

Official title:

Urodynamic Analysis of the Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262816
• Other study ID #: SAHoWMU-CR2021-15-103
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Junyan Lu
• Phone: 13968769904
• Email: huars03[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with traumatic suprasacral SCI.

• the period of the spinal shock has passed.

• patients with voiding dysfunction after SCI.

• patients had stable condition, and suitable for treatment.

• agreed to engage in our study and sign the informed consent.

Exclusion Criteria:

• Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.

• dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.

• Patients who have already taken cystostomy and sacral electrode implantation.

• Patients with urinary tract infection.

• Autonomic hyperreflexes were obvious.

• Unable to cooperate with the healer.

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

Other:
• electroacupuncture
electroacupuncture at Sanyinjiao (SP6)

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perianal surface electromyography	Perianal surface electromyography	Procedure (While doing acupuncture )
Primary	detrusor overactivity (DO)	detrusor overactivity in milliliter,one of the urodynamic parameters	Procedure (While doing acupuncture )
Primary	bladder compliance (BC)	bladder compliance in ml/cmH2O,one of the urodynamic parameters	Procedure (While doing acupuncture )
Primary	maximum cystometric capacity (MCC)	maximum cystometric capacity in milliliter,one of the urodynamic parameters	Procedure (While doing acupuncture )
Primary	maximum urinary flow rate (Qmax)	maximum urinary flow rate in milliliter/second,one of the urodynamic parameters	Procedure (While doing acupuncture )
Primary	maximum detrusor pressure	maximum detrusor pressure at filling stage and voiding stage	Procedure (While doing acupuncture )